Completed Final Milestone with Medtronic
Selected Benchmark to Manufacture Enos System Expanded Patent
Portfolio to More Than 200
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company focused on the development and commercialization of
innovative surgical technologies for single access robotic-assisted
surgery (RAS), today announced financial results for the three and
twelve months ended December 31, 2021.
Key Accomplishments and Recent Activities
- Received payment and retired senior secured loan from Medtronic
after completion of final milestone under development agreement
- Net payment of $8.3 million received
- Retired senior secured loan of $2.3 million
- Selected Benchmark to manufacture Enos system surgeon
workstation and patient cart
- Manufactured units will be integrated with proprietary cameras
and multi-articulating instruments to be manufactured at Titan’s
Chapel Hill facility
- Expanded patent portfolio to more than 200 patents and
applications
- Continue to evaluate options for geographical expansion and
revenue generating opportunities with third parties
- Comprehensive RAS patent portfolio includes coverage in the
United States, Europe, Canada, China, Japan, Korea and
Australia
- Completed buildout of Chapel Hill facilities
- Increased footprint to serve as a controlled manufacturing
space. Procurement of parts for assembly of cameras and instruments
underway, as well as processes for lifecycle testing
- Announced CEO transition
- Paul Cataford named as Interim President and CEO. The company
has commenced a process to identify a permanent CEO using a top
tier recruiting firm
- Attended Society of American Gastrointestinal and Endoscopic
Surgeons (SAGES) annual meeting, March 16-18, 2022
- Deepak Basra, VP Strategy & Business Development and Chris
Seibert, VP Upstream Marketing attended SAGES and met with surgeons
to discuss innovations in the development of the Enos system, and
assessed the potential for the downstream integration of advanced
software, including artificial intelligence and machine learning,
to further enhance the patient experience
- Paul Cataford presented and participated in the H.C. Wainwright
& Co. BioConnect 2022 Conference on January 10, 2022 and in
Oppenheimer’s 32nd Annual Investor Conference on March 15,
2022
The company remains on track with activities to support a De
Novo classification request with the U.S. Food and Drug
Administration (FDA) in 2024. Utilizing the Q-Submission Program,
the company has engaged in ongoing dialogue with the FDA to clarify
requirements in an effort to mitigate against risks to the
development plan and timeline. The company plans to file the IDE
application with the FDA in the first quarter of 2023 and
anticipates receiving a response on the IDE from the FDA in the
first half of 2023. Following IDE approval, the company expects to
start the IDE human clinical study in the second half of 2023. Upon
completion, the company plans to submit a De Novo application in
2024. Commercial launch of the Enos system will begin upon receipt
of marketing authorization from the FDA, anticipated in early
2025.
“Our focus and commitment are on executing against our IDE
submission milestone. Design transfer to our capital equipment
contract manufacturing partner continues and we are currently on
track to begin system verification and validation testing later
this year. We have completed the build-out of our in-house
manufacturing facility in Chapel Hill to assemble our proprietary
RAS cameras and instruments, that will be used in clinical trials,”
stated Paul Cataford, Interim President and CEO of Titan. “Our
team’s ability to execute is key as we deliver on our mission to
bring the innovative Enos system to market to benefit patients,
while addressing feedback from surgeons and improving hospital
economics. Our interactions with the FDA continue to be
collaborative as we finalize our IDE submission package and work on
requirements for our clinical trials. With a regulatory
authorization process established and the team properly resourced,
we are excited about our progress and the opportunity that we have
to bring to market an advanced surgical experience for patients and
surgeons,” added Mr. Cataford.
Financial Highlights
As of December 31, 2021, Titan had cash and cash equivalents of
$32.3 million, compared to $25.5 million at December 31, 2020.
For the year ended December 31, 2021, research and development
(R&D) expenses were $37.9 million compared to $7.9 million in
the comparative period. R&D expenses were related to the
development of the Enos system and development activities under the
development and license agreement with Medtronic. Comparatively, in
the first half of 2020, the company temporarily suspended R&D
activities and then, following execution of the Medtronic
agreements in June, initiated the establishment of in-house
development capabilities in Chapel Hill, North Carolina.
For the three months ended December 31, 2021, R&D expenses
increased to $10.8 million compared to $5.5 million for the for the
three months ended December 31, 2020. In the quarter, R&D
expenses related to the development of the Enos System and the
development work required to achieve the final milestone under the
Development Agreement with Medtronic. In the comparative period,
the R&D expenses related to the establishing a new facility in
Chapel Hill, North Carolina to focus on the development of the Enos
System and development work required to complete the milestone
under the Development Agreement with Medtronic.
General and administrative (G&A) expenses were $12.4 million
for the year ended December 31, 2021 compared to $7.6 million in
the comparative period. The increase in G&A expenses in 2021
compared to 2020 is related to an increase in stock-based
compensation of $2.6 million, $0.7 million in severance costs,
expansion of the senior leadership team to support the development
of the Enos system and professional fees related to market
research. Adjusting for non-cash stock-based compensation expenses
and one-time severance expenses, G&A expenses for 2021 were
$8.1 million compared to $6.5 million in 2020, primarily due to
expansion of the leadership team to support the development of the
Enos system.
G&A expenses increased to $2.0 million for the three months
ended December 31, 2021 compared to $1.4 million for the three
months ended December 31, 2020. The increase in G&A expenses is
related to $0.5 million in severance costs and an increase in
stock-based compensation.
With respect to the Nasdaq notification regarding minimum bid
price deficiency received on December 30, 2021, the company is
evaluating all options to regain compliance with Nasdaq Rule
5550(a)(2) prior to the June 28, 2022 deadline.
The company’s audited annual financial statements and MD&A
are available at www.sedar.com and/or at www.sec.gov.
Investor Audio Webcast Information
Titan Medical will host an investor audio webcast at 8:30 a.m.
ET today (March 24, 2022) to discuss the company’s financial
results for the three and twelve months ended December 31, 2021,
and recent business highlights. The webcast can be accessed via the
Investor Relations section of the company’s website
www.titanmedicalinc.com.
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company headquartered in Toronto, Ontario and with operations in
Chapel Hill, North Carolina, is focused on enhancing robotic
assisted surgery using innovative technology through a single
access point. The Enos™ robotic single access surgical system is
being developed with an ergonomic focus to provide a surgical
experience that imitates real-life movements that surgeons demand
and includes multi-articulating instruments designed to allow
surgeons an increased range of motion in a confined space, with
dexterity and the ability to exert the forces necessary to complete
common surgical tasks. With the Enos system, Titan intends to
initially pursue gynecologic surgical indications.
Enos™ is a trademark of Titan Medical Inc.
For more information, visit www.titanmedicalinc.com and follow
@TitanMedical on Twitter and LinkedIn.
Forward-Looking Statements
This news release contains “forward-looking statements” within
the meaning of applicable Canadian and U.S. securities laws, which
reflect the current expectations of management of the company’s
future growth, results of operations, performance, and business
prospects and opportunities. Forward-looking statements are
frequently, but not always, identified by words such as “may”,
“would”, “could”, “will”, “anticipate”, “believe”, “plan”,
“expect”, “intend”, “estimate”, “potential for” and similar
expressions, although these words may not be present in all
forward-looking statements. Forward-looking statements that appear
in this release may include, without limitation, references to: the
company’s focus on the development and commercialization of its
innovative surgical technologies for single access robotic-assisted
surgery; the company’s plans to manufacture and integrate
proprietary cameras and multi-articulating instruments with
manufactured Enos system units; the company’s plans to evaluate
options for geographical expansion and revenue generating
opportunities with third parties with respect to its patent
portfolio; the company’s plans for manufacturing at its Chapel Hill
facilities; the Company’s plans to resolve the Nasdaq minimum bid
price deficiency; the process to identify a permanent CEO; the
downstream integration of advanced software, including artificial
intelligence and machine learning, with the Enos system; the
company’s activities to support a De Novo classification request
and its discussions with the FDA, including its expectations with
respect to timing for filing an IDE application, starting a IDE
human clinical study, submission of a De Novo application, and the
commercial launch of the Enos system; the company’s progress with
its capital equipment contract manufacturing partner including with
respect to system verification and validation testing; the
company’s belief in bringing to market an advanced surgical
experience; the company’s intention to host an upcoming investor
audio webcast; the Enos robotic single access surgical system being
developed with an ergonomic focus to provide a surgical experience
that imitates real-life movements that surgeons demand; and that
Titan intends to initially pursue gynecologic surgical indications.
These statements reflect management’s current beliefs and are based
on information currently available to management. Forward-looking
statements involve significant risks, uncertainties, and
assumptions. Many factors could cause the company’s actual results,
performance, or achievements to be materially different from any
future results, performance or achievements that may be expressed
or implied by such forward-looking statements, including, without
limitation, those listed in the “Risk Factors” section of the
company’s Annual Report for the fiscal year ended December 31, 2021
(which may be viewed at www.sedar.com and at www.sec.gov). Should
one or more of these risks or uncertainties materialize, or should
assumptions underlying the forward-looking statements prove
incorrect, actual results, performance, or achievements may vary
materially from those expressed or implied by the forward-looking
statements contained in this news release. These factors should be
considered carefully, and prospective investors should not place
undue reliance on the forward-looking statements. Although the
forward-looking statements contained in the news release are based
upon what management currently believes to be reasonable
assumptions, the company cannot assure prospective investors that
actual results, performance or achievements will be consistent with
these forward-looking statements. Except as required by law, the
company expressly disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new
information, future events or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220324005157/en/
Kristen Galfetti Vice President, Investor Relations &
Corporate Communications +1-781-869-2553
investors@titanmedicalinc.com
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